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Quality Assurance Consulting

Quality assurance consulting, often referred to as quality systems consulting or quality management consulting, is in great demand—and with good reason. Today’s manufacturers face intense pressure to comply with an endless array of regulations, standards and quality initiatives from regulators around the world. In addition, consumers expect them to provide better, cheaper products. The most effective way to satisfy both groups is to prevent defects and manage quality and costs with the help of a robust quality management system (QMS). If you don’t have a QMS, An experienced quality consulting firm can help you develop a QMS from scratch, or assess whether your current QMS is compliant with new and existing regulations and meeting your customers' needs.

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Demo Video: MasterControl Quality Management System (QMS) Overview

Do You Need Quality Systems Consulting?

One of the major hurdles quality professionals must overcome is to convince management that regulatory compliance is a team effort, not solely the responsibility of the quality department. A quality consulting firm can help you communicate this message to, and refute the assumption that quality and compliance are impediments to innovation—necessary, but costly evils. Streamlining and standardizing quality processes, such as CAPA and risk management, can actually give your organization a huge competitive edge.

How can you tell if your QMS is working for—or against—you? Can you locate the SOPs you need, when you need them? Are your work instructions clear and concise or complex and ambiguous? Do you have the proper design controls in place? Is your system bogged down by too many open CAPAs? Are you using risk to evaluate and manage quality events? Are you ready for your next audit or inspection? The answers to these questions will help you determine if your QMS could benefit from professional quality systems consulting services.

A sound QMS can cut operating costs, increase productivity, improve product safety, protect brand equity, and provide access to international markets. If you suspect your QMS is not operating at the peak of efficiency, an experienced quality assurance consulting firm can help you quickly identify and correct what is keeping you from realizing your full business potential.

Hiring a Quality Assurance Consulting Firm vs. Doing it In-House

Once you’ve determined that your QMS—or a particular process within your QMS—isn’t up to par, the next step is to convince management to hire an external quality assurance consulting firm rather than rely on internal resources. Here are just a few benefits that professional quality systems consulting can bring to your organization:

Objective Perspective: Although it may be clear to you and other team members what’s causing the bottleneck in your QMS, or what needs to be done in order to correct it, communicating it can be difficult for internal resources. However, an external quality system consulting professional, doesn’t have to play office politics or worry about the consequences of stepping on a superior’s toes. He or she can speak about the issues based on facts and data, without internal relationships or company culture coming into play. This allows them to facilitate and implement change much faster.

A Fresh Pair of Eyes: Even the most competent internal people can benefit from a new set of eyes. It’s easy to fall into the “this is how we’ve always done it” mindset. Much like an editor is employed to uncover issues overlooked by the book author, who is extremely too close to catch everything.

Finding a consulting firm that not only understands your industry, but also your business can be daunting. It’s worth the effort, however, particularly if your company lacks the time, resources or internal expertise to develop an effective QMS from scratch, or to verify that its existing quality processes are working as well as they should (or could) be.

For more information For more information on our quality assurance consulting services Contact us today.

The QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).